05-26-oreardon.fm

A Randomized, Placebo-Controlled Trial of Sertraline in the Treatment of Night Eating SyndromeJohn P. O’Reardon, M.D.Objective: The authors assessed the effi-
placebo. Twelve subjects in the sertraline
group (71%) were classified as having re-
Kelly C. Allison, Ph.D.
sponded (CGI improvement rating ≤2, in-dicating much or very much improved)
Method: Thirty-four outpatients diag-Nicole S. Martino, B.A.Jennifer D. Lundgren, Ph.D.
traline (N=17) or placebo (N=17) in an 8-week, double-blind, flexible-dose (50–200
CGI severity ratings, quality of life ratings,
Moonseong Heo, Ph.D.
mg/day) study. A mixed effects linear re-
Albert J. Stunkard, M.D.
Clinical Global Impression (CGI) improve-
jects in the sertraline group (N=14) lost a
ingestions, total daily caloric intake after
placebo (N=14) (mean=–0.3 kg, SD=2.7).Conclusions: In this 8-week trial, sertra-
quality of life ratings, and weight.Results: Sertraline was associated with
night eating syndrome and was well toler-
(Am J Psychiatry 2006; 163:893–898)
Night eating syndrome is an eating disorder charac- more common in obese persons than in nonobese per-
terized by morning anorexia, evening hyperphagia, and
sons and to increase in prevalence with increasing adipos-
insomnia with awakenings followed by nocturnal inges-
ity. In a Danish study (7), female obese subjects exhibiting
tions (1, 2). In addition, mood is usually low (3), with a pat-
night eating gained 5 kg over a 6-year period, whereas fe-
tern of worsening in the latter half of the day (2). The core
male obese subjects who did not engage in night eating
feature of night eating syndrome appears to be delay in
gained 1 kg. About half of individuals with night eating
the circadian timing of food intake (4). Food intake is
syndrome report that they were of normal weight before
lower in the first half of the day and greater in the evening
the syndrome developed, suggesting that night eating syn-
and nighttime. Sleep is often disrupted in the service of
drome may be an important pathway to obesity (8).
food ingestion. In the largest controlled study to date of
There have been few reports on the treatment of night
overweight and obese outpatients with night eating syn-
eating syndrome. Case reports have suggested benefit from
drome (4), energy intake in the first 8 hours of the day (6:00
a variety of strategies including d-fenfluramine (9), photo-
a.m. to 2:00 p.m.) averaged only 575 kcal in night eating
therapy (10), progressive muscular relaxation (11), and
syndrome subjects (N=46) versus 1,082 kcal in a compari-
topiramate (12). The first clinical pharmacotherapy trial
son group (N=43), whereas energy intake in the last 8
(13) was a 12-week, open-label study of 17 subjects treated
hours (10:00 p.m. to 6:00 a.m.) averaged 591 kcal in night
with sertraline, a selective serotonin reuptake inhibitor
eating syndrome subjects versus only 118 kcal in compar-
(SSRI). A significant reduction of symptoms was seen in
ison subjects. The total energy intake over 24 hours was
obese subjects with night eating syndrome, with about half
not different between the two groups.
(N=8) of the group responding to sertraline. Those respond-
Night eating syndrome is of clinical importance because
ers who achieved remission of night eating syndrome (N=5)
it is associated with both obesity and psychological dis-
also lost a significant amount of weight (–4.8 kg, SD=2.6).
tress. Its prevalence has been estimated at 1.5% in the gen-
The present study sought to follow up this previous open-
eral population (5) with a reported range of 8.9% (6) to
label trial with a double-blind, randomized, placebo-con-
14% (3) in obesity clinics and rates of up to 27% in severely
trolled trial. This time we also included a small number of
obese persons (5). Night eating syndrome appears to be
normal weight subjects with night eating syndrome to deter-
SERTRALINE AND NIGHT EATING SYNDROME
mine if sertraline might relieve the distress associated with
four tablets daily. Medication tolerance and adherence were re-
Subjects were weighed at each visit and completed three self-
report scales: 1) a night eating symptom scale, 2) the Beck De-
pression Inventory, and 3) the Quality of Life Enjoyment and Sat-isfaction Questionnaire. The night eating symptom scale is a self-
Subjects were recruited from a study that characterized the psy-
report scale measuring the range and severity of night eating
chological and behavioral aspects of night eating syndrome (4).
symptoms over the preceding week (13). It measures in a series of
These patients were recruited through a combination of print ad-
13 items the degree of morning anorexia, evening hyperphagia,
vertisements, TV programming, and a website. The characteriza-
sleep disturbance, nocturnal eating episodes and associated
tion study included 1) a structured clinical interview designed to as-
cravings or compulsion to eat, and level and pattern of mood dis-
sess the presence or absence of night eating syndrome, performed
turbance. Each item is scored from 0 to 4, providing a possible
by a trained clinician; 2) a 10-day sleep and food diary; 3) the Struc-
range of scores from 0 to 52. The study physician recorded the
tured Clinical Interview for DSM-IV (SCID) to assess the presence of
number of nighttime awakenings (defined as when the subject
past or current psychiatric disorders; and 4) the Eating Disorder Ex-
got up out of bed for reasons other than solely to use the bath-
amination to assess the presence of concomitant eating disorders.
room) and ingestions. The study physician also administered theClinical Global Impression (CGI) improvement and severity
Participants
scales and the 17-item Hamilton Depression Rating Scale at each
Eligible subjects were at least 18 years of age, met standard cri-
visit. The Hamilton and Beck instruments were used to track
teria for night eating syndrome according to the structured clini-
changes in depressive symptoms. Outcome was categorized at
cal interview, and had a body mass index (BMI) >18 kg/m2. Appli-
week 8 on the basis of the CGI improvement rating, which ranges
cants were excluded if they 1) were severely depressed (symptoms
from 1 to 7. CGI improvement ratings were considered a primary
in excess of the number required for DSM-IV diagnosis and mark-
outcome measure, with a priori standards applied as follows: sub-
edly interfering with occupational functioning or with usual so-
jects with scores of 2 (much improved) were categorized as having
cial activities or relationships); 2) had a lifetime diagnosis of bipo-
responded, and those with scores of 1 (very much improved) were
lar disorder or any psychotic disorder; 3) reported substance
abuse or dependence within the preceding 6 months; 4) were cur-
Evening hyperphagia was assessed by reviewing with the sub-
rently taking psychotropic medications (including hypnotics); 5)
ject the proportion of their daily caloric intake that occurred be-
were working a night shift or swing shift schedule; 6) were in a
tween the end of the evening meal and bedtime plus any noctur-
weight reduction program; 7) had a current diagnosis of anorexia
nal ingestions that occurred. As some subjects with night eating
nervosa or bulimia nervosa (but not binge eating disorder); or 8)
syndrome delay their evening meal considerably as part of the
lacked awareness of their night eating episodes. The latter crite-
circadian delay in the food intake rhythm, a cutoff of 8:00 p.m.
rion was used to exclude subjects with nocturnal sleep-related
was used. Any food intake commencing after this time was con-
eating disorder, a parasomnia in which nocturnal eating is ac-
sidered to be caloric intake after the evening meal. The total ca-
companied by a lack of awareness at the time and subsequent
loric intake after the evening meal represents the sum of calories
ingested between the end of the evening meal and bedtime plusany calories derived from nocturnal ingestions; it is expressed as
Procedures and Measures
a percentage of total 24-hour calorie intake.
Baseline night eating syndrome symptoms were assessed as
The Institutional Review Board of the University of Pennsylva-
part of the characterization of night eating syndrome study (4).
nia approved the protocol. All subjects signed the informed con-
Each subject collected data in a food and sleep diary during a 10-
sent form after study procedures had been fully explained.
day 24-hour prospective monitoring period, with the first 2 days
Data Analysis
discarded as practice days and the last day discarded because ofincomplete data. The diary included a record of all meals, snacks,
Means and standard deviations of the outcome variables at
and beverages consumed. Awakenings (during which the subject
each time point were used for descriptive statistics as well as for
got out of bed), nocturnal ingestions, as well as the timing of bed-
the depiction of trends over the 8 weeks. The analyses were con-
time and morning awakening were all recorded. A research dieti-
ducted on an intent-to-treat basis for all subjects who completed
cian analyzed diaries for caloric intake and macronutrient con-
at least one follow-up visit after the baseline visit. The repeated-
tent. Subjects were paid for the baseline diary data collection but
measures outcome variables over the 8-week period were ana-
not for participation in the treatment trial itself. Of the 65 subjects
lyzed by a mixed effects linear regression model in the following
with night eating syndrome who completed the diary assessment,
form: outcome variable=intercept + group + week + group x week.
28 who were eligible to participate in the trial decided not to. Rea-
The intercept was assumed to be random in order to take within-
sons for not participating were inability to schedule (N=16), not
subject correlations of the dependent variables into account for
wanting to be in a placebo-controlled study (N=7), and not want-
statistical inference. Group and time variables were taken as fixed
ing a medication (N=5). This left a total of 37 subjects who entered
and discrete; two-sided p<0.05 was considered significant. This
the treatment trial. Three subjects attended the baseline visit but
mixed effects modeling approach with available cases using a
did not return for any subsequent visits, leaving a total of 34 sub-
maximum likelihood method is valid in the presence of observa-
jects whose data were included in the analyses.
Subjects were randomly assigned to 8 weeks of double-blind
The effects of particular interest were the main group effect
treatment with sertraline or placebo. Psychotropic agents other
and the group-by-week interaction, with this interaction repre-
than the study medication were prohibited during the study. The
senting differences in trends of the outcome variables over time
8-week duration of the trial was based on the results of our earlier
between night eating syndrome and comparison groups. Omni-
12-week trial. Subjects took tablets, identical in appearance, con-
bus interaction significance tests are reported in the text. Post hoc
taining either 50 mg of sertraline or placebo. Subjects com-
testing of the main group effects at each time point on the out-
menced with one tablet daily taken with the evening meal. Sub-
come variables was followed by testing of the corresponding pa-
jects were seen every other week for 30-minute visits at which
rameter contrasts in the mixed effects model with Wald t tests. For
time medication dosage could be adjusted up to a maximum of
this purpose, we used a Bonferroni-corrected significance level
O’REARDON, ALLISON, MARTINO, ET AL.TABLE 1. Demographic and Clinical Characteristics at Baseline Among Subjects With Night Eating Syndrome Randomly As-signed to 8 Weeks of Double-Blind Treatment With Sertraline or Placebo
Duration of night eating syndrome (years)
Quality of Life Enjoyment and Satisfaction Questionnaire score
a Obtained from self-report ratings of 13 items (score range=0–52).
0.05/4=0.0125 (correcting for the number of treatment visits after
none of the three normal weight subjects in the placebo
baseline), except when testing for correlations. Main group ef-
fects at any week with p values lower than this corrected signifi-
Figure 1 shows that the largest reduction in symptoms
cance level were declared to be significant even if the overall maingroup or interaction effects were not significant.
occurred between baseline and week 2, indicating an early
Three subjects who met criteria for binge eating disorder in ad-
and robust effect of sertraline. Overall, a subject receiving
dition to night eating syndrome were included as part of the sam-
sertraline had a 30% chance of responding by week 2. Five
ple. In line with recent evidence, binge eating disorder and night
of the 12 who ultimately responded to sertraline had re-
eating syndrome appear to be two distinct disorders rather than
sponded as early as week 2, and four of these five achieved
variable expressions of the same underlying psychopathology
remission status by week 2. The lack of early improvement
(15, 16). In this respect, binge eating disorder was treated as a co-morbid condition in night eating syndrome subjects and was not
with sertraline did not preclude ultimate response, as 50%
viewed as exclusionary for study participation. All three subjects
of all responses occurred between weeks 4 and 8.
with binge eating disorder plus night eating syndrome were ran-
The CGI severity scale is a further index of overall
domly assigned to the placebo group. We tested for the signifi-
change in night eating syndrome symptoms. The sertra-
cance of binge eating disorder by including binge eating disorderstatus in the aforementioned mixed effects models. Binge eating
line group had a reduction of two points in symptom se-
disorder status did not have a significant effect on any of the out-
verity, from 4.2 at baseline (moderate severity) to 2.2 at
comes except for caloric intake after the evening meal. Thus, ca-
endpoint (borderline ill), whereas there was a much more
loric intake after the evening meal was the only variable for which
modest reduction (from 4.2 to 3.4) in the placebo group
binge eating disorder status was controlled. Pearson’s correla-
tions were used to assess the association of changes at week 2with those at week 8 in the SSRI group. We used SAS v8.2 for sta-
Night Eating Symptoms
Changes in night eating syndrome symptoms were sig-
nificantly greater in the sertraline group, as assessed bynight eating symptom scores over the course of the 8-week
Characteristics of the sertraline and placebo groups at
baseline are presented in Table 1. No significant between-
By week 8, the night eating symptom scores of the sertra-
group differences for these variables were found.
line group had dropped by 18.1 points (57%) from a base-line score of 31.7 as compared with a reduction of only 5
CGI Ratings
points (16%) from a baseline score of 30.5 in the placebo
The CGI improvement rating classified 12 of the 17 sub-
group (F=8.0, df=4, 112, p<0.0001). A significant correlation
jects receiving sertraline as having responded (score ≤2),
was found between the change in night eating symptom
and seven of these 12 achieved remission or complete res-
scores from baseline to week 2 and the change from base-
olution of night eating syndrome symptoms (F=6.7, df=4,
line to week 8 for subjects receiving sertraline (r=0.68, p=
113, p<0.001). Of those receiving placebo, only three sub-
0.01), indicating that early improvement with sertraline was
jects were classified as having responded (a response rate
predictive of ultimate response. In addition, in terms of the
significantly lower than that seen with sertraline [χ2=9.66,
speed of response, the dose at first observed response in the
df=1, p<0.002]), with one of the three placebo responders
sertraline group was correlated with the week of response,
achieving remission status. Of the three normal weight
suggesting that those responding early improved at lower
subjects in the sertraline group, two responded, while
doses than those responding later (r=0.84, p<0.001). How-
SERTRALINE AND NIGHT EATING SYNDROMEFIGURE 1. Changes in CGI Improvement Ratings and NightFIGURE 2. Changes in Frequency of Awakenings and Noc-Eating Symptoms Over the Course of the Study in Subjectsturnal Ingestions in Subjects With Night Eating SyndromeWith Night Eating Syndrome Randomly Assigned to 8Randomly Assigned to 8 Weeks of Double-Blind TreatmentWeeks of Double-Blind Treatment With Sertraline or Pla-With Sertraline or Placebo estions –2 Noctur –6vement Ro 2CGI Impr 1e in Number ofeningsak –2ting Symptom Scale 20e in Number ofe on Night Ea 5Chang –10
ever, the probability of response by the study endpoint at
week 8 was not correlated with dose, indicating that doseper se was not an important predictor of ultimate response
groups (F=4.7, df=1, 32, p=0.03). In post hoc testing, after
adjustment for multiple comparisons, the difference at
Ingestions and Awakenings
week 8 was not significant (t=–2.52, df=80, p=0.0137).
Figure 2 shows a significant reduction in the frequency
Caloric Intake After the Evening Meal
of nocturnal ingestions in the sertraline group relative to
Figure 3 shows that caloric intake after the evening meal
the placebo group. The number of nocturnal ingestions in
in the sertraline group fell by 68%, from 47.3% of total daily
the sertraline group fell by 81% (from a mean at baseline of
calories at baseline to 14.8% at week 8. In the placebo
8.3 per week [SD=8.5] to 1.6 [SD=2.6]) versus a fall of only
group, caloric intake after the evening meal fell by 29.3%,
14% for the placebo group (from 6.4 [SD=4.9] to 5.5 [SD=
from 44.7% at baseline to 31.6% at week 8 (F=3.5, df=4,
4.9] per week) (F=3.7, df=4, 80, p=0.01). Figure 2 indicates
106, p=0.009). Comparisons of individual time points were
that the number of awakenings fell by 74% in the sertraline
not significant (week 8: t=2.0, df=106, p=0.047).
group (from a mean of 8.8 per week [SD=8.6] to 2.3 [SD=4.7]) versus a fall of only 14% in the placebo group (from
Weight Change
6.4 [SD=4.6] to 5.5 [SD=5.0]). This drop failed to reach sig-
Among overweight subjects (N=14 in both groups), the
nificance in the overall interaction effect (F=0.9, df=4, 80,
sertraline group lost 2.9 kg (SD=3.8) versus 0.3 kg (SD=2.7) in
p=0.40), but it yielded a difference in main effect between
the placebo group (F=2.6, df=4, 63, p=0.06). The difference in
O’REARDON, ALLISON, MARTINO, ET AL.
main effect for weight between groups at week 8 was signifi-
FIGURE 3. Changes in Caloric Intake After the Evening Meal
cant (t=–2.7, df=63, p=0.009). The three normal weight sub-
and Weight in Subjects With Night Eating Syndrome Ran-domly Assigned to 8 Weeks of Double-Blind Treatment
jects receiving sertraline lost 1.2 kg compared with a gain of
With Sertraline or Placebo
0.3 kg by the three normal weight subjects receiving placebo.Mood Measures
Mood measures showed only a modest level of depressive
symptoms in both groups at baseline (Table 1), and they did
not differ over time (Hamilton score change: F=1.5, df=4,110, p=0.20; Beck score change: F=1.9, df=4, 100, p=0.10).
Change in night eating symptom scores in the sertraline
group did not significantly correlate with reduction in de-
e After Supper (%) 30
pressive symptoms as assessed with either the Beck De-pression Inventory (r=0.26) or Hamilton depression scale
(r=0.08). When the two depression items were removedfrom the full night eating symptom scale, the score on the
Caloric Intak
modified scale still correlated strongly with the full scale
score (r=0.98, p<0.001), implying that change in depres-sive symptoms was not the principal driver of change in
Quality of Life
In the sertraline group there was an increase in score on
the Quality of Life Enjoyment and Satisfaction Question-
naire, from 47.1 (SD=12.0) at baseline to 54.3 (SD=9.6) at
week 8. Those receiving placebo remained essentially un-
changed (mean=47.6 [SD=9.9] at baseline and 47.4 [SD=
7.3] at week 8; F=2.5, df=4, 108, p=0.045). No differenceswere noted at specific time points.ight ChangeW –3Dosing and Adverse Events
The mean daily dose of sertraline at study endpoint was
126.5 mg (SD=50.4). In contrast, the average dose of pla-
cebo attained would have translated to 173.5 mg (SD=
40.0), indicating that dose was appropriately increased
when a suboptimal response was observed (t=3.0, df=32,
p=0.005). Sertraline was well tolerated, and no subject
withdrew because of adverse events. Common side effects
were mild and included dry mouth, fatigue, diminished li-bido, and sweating. Nausea as an adverse event was infre-
evening meal dropped from 47.3% of total daily calories
quent and transient (affecting two subjects receiving pla-
consumed at baseline to 14.8% at week 8, thus approach-
cebo and one receiving sertraline). There were two
ing the normative levels of intake for obese comparison
dropouts in the study, each related to lack of efficacy, one
subjects without night eating syndrome found in our pre-
from the sertraline group at week 6, and one from the pla-
Consistent with the reduction in evening and nocturnal
hyperphagia are the weight losses (about a pound a week),
Discussion
which were similar to those in our earlier, open-label trial
The results of this study, the first randomized, placebo-
with sertraline (13). This finding is the more striking in
controlled trial of sertraline in the treatment of night eat-
that no advice or behavioral guidance regarding weight
ing syndrome, are clear. Sertraline, an SSRI medication,
loss was given. It suggests that sertraline may have a re-
reduced the symptoms of night eating syndrome, and
straining effect on the tendency to gain weight in persons
most subjects (71%) met response criteria at the end of 8
weeks. The extent of improvement in core night eating
Two patterns of improvement with sertraline were evi-
syndrome symptoms was striking. The number of noctur-
dent. Five subjects experienced an early and robust im-
nal ingestions in the sertraline group was reduced by
provement with sertraline, meaning that close to half of
about 80% by study endpoint. The caloric intake after the
those ultimately responding (N=12) exhibited this re-
SERTRALINE AND NIGHT EATING SYNDROME
sponse after only 2 weeks of receiving active medication.Improvement in the seven other responders occurred
Received Feb. 11, 2005; revision received July 15, 2005; accepted Oct.
19, 2005. From the Department of Psychiatry, University of Pennsylvania.
more gradually, between weeks 4 and 8. The fact that there
Address correspondence and reprint requests to Dr. O’Reardon, Depart-
was only a weak, nonsignificant correlation between im-
ment of Psychiatry, University of Pennsylvania, Rm. 4005, 3535 Market
provement in depressive symptoms among night eating
St., Philadelphia, PA 19104, [email protected] (e-mail).
Supported by grants from the National Institute of Diabetes and Di-
syndrome subjects receiving sertraline and improvement
gestive and Kidney Diseases (R01 DK56735) and Pfizer Inc.
in night eating symptoms strongly implies that the im-provement with sertraline was independent of its antide-pressant effect.References
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The Newsletter for Clients of Celtic Hands Massage As this issue goes to press, I am tentatively planning on taking a vacation to visit family and As our world grows ever more complex, we friends in Arizona and Southern California from often become “stressed out.” Most of us think November 26th through December 5th. Since I stress results from those times when everything won’t ha